Natco Pharma, Bristol-Myers Squibb face off in Court over sale of dasatinib clone

NEW DELHI: US-based pharma major Bristol-Myers Squibb has filed a contempt suit against India's Natco Pharma for allegedly violating a court order that prevents it from selling a generic version of its patented cancer drug dasatinib.

Hyderabad-based Natco, however, says it has not reneged on its undertaking as its version of the drug is different and does not infringe upon the patent for dasatinib. The generic firm has filed its own contempt petition "for misinterpreting facts to the court".

Legal experts, however, say the court orders are open to interpretation. The matter is scheduled for hearing in the Delhi High Court on Wednesday.

A spokesman for Bristol-Myers Squibb refused comment on the litigation, but said, "The company has, and will continue to pursue all appropriate legal avenues to protect its intellectual property rights in India."

Natco Pharma officials declined comment.

In June, the Delhi High Court had ordered Natco to stick to the undertaking it had given in court in 2009 that it will not manufacture or sell a generic version of dasatinib.

Bristol-Myers, which sells dasatinib under the trade name Sprycel, had sought a stay order in 2009 when Natco approached the central drug controller's office for marketing approval for a cheaper version of the medicine.

The Mumbai patent office had granted patent for dasatinib to Bristol-Myers in 2006.

Kolkota-based patent expert Shamnad Basheer said Natco may have "committed a fatal legal blunder" by giving such a commitment. "The key issue now boils down to whether Natco launched a generic version of Sprycel (dasatinib) or not," he said.

Natco has been spearheading Indian generic firms' challenge of patents granted to multi-national drugmakers. In May, it bagged the country's first compulsory licence, which allowed it to manufacture and sell a generic version of Bayer AG's cancer drug Nexavar in the country.

People close to the development said that there was also an attempt to get Natco's marketing licence revoked, but Natco has no plans to withdraw its drug from the market.